Daytime Cold and Flu Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Daytime Cold and Flu Relief

ARMY AND AIR FORCE EXCHANGE SERVICE

Exchange Select 44-534


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each liquid cap)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Daytime Cold and Flu Relief Uses

  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • fever
    • cough due to minor throat and bronchial irritation

Warnings

Liver warning: This product contains acetaminophen.  Severe liver damage may occur if you take:

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you don't know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • liver disease
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed
    (see overdose warning)
  • do not take more than 4 doses per 24 hours
  • adults and children 12 years and over: take 2 liquid caps with water every 6 hours
  • children under 12 years: ask a doctor

Daytime Cold and Flu Relief Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, white edible ink

Questions or comments?

1-800-426-9391

Principal display panel

exchange select X

Compare To The Active Ingredients of Vicks® DayQuil® Liquicaps®*

DAYTIME
Cold & Flu Relief
Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl

MULTI-SYMPTOM Non-Drowsy
• Aches, Fever, Sore Throat
• Nasal Congestion
• Cough

Alcohol Free • Antihistamine Free
24 LIQUID CAPS

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Liquicaps®.
50844    REV0113B53408
PRODUCT OF CANADA

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Daytime Cold and Flu Relief
Exchange Select 44-534

Daytime Cold and Flu Relief

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55301-534
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
sorbitol
FD&C YELLOW NO. 6
FD&C RED NO. 40
water

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Transparent) 21 mm 95A CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:55301-534-08 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-09-19


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Be sure to consult your doctor before taking any medication!
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